1.Inhloso yokuqinisekisa i-eto inzalo
1.1.ukutholwa kobufakazi bokuqinisekisa bokuqinisekisa ukuthi i-eto inzalo iqinisekisa ukuthi okokusebenza okusetshenziselwa ukuvalwa kwe-ETO kuhlinzekiwe futhi kwafakwa ngokuvumelana nencazelo yayo futhi ingasebenza ngokuzinza ngaphakathi kwemikhawulo enqunywe kusengaphambili futhi yenze ngokungaguquki ngokuvumelana nemibandela enqunywe kusengaphambili futhi ngaleyo ndlela ikhiqize umkhiqizo uhlangabezana nokucaciswa kwawo.
1.2
Le ngxenye icacisa izidingo zokuthuthukiswa, ukuqinisekiswa kanye nokulawulwa okujwayelekile kwenqubo yokuvala inzalo ye-ETO futhi inikeze umhlahlandlela wokuthi ihambisane nezidingo zokulawula ezifanele ezifana ne-ISO 11135.
2. Ububanzi
2.1.Izinto ezisetshenziswayo ezifanele ezisetshenziswa e-ETO inzalo(Igumbi le-Precondition?I-Sterilizer?Igumbi lokungenisa umoya?I-Incubator, njll.).
3. Imigomo Nezincazelo
3.1.?IQ
Ukufaneleka kokufakwa:IQ
3.2.?OQ
Ukufaneleka kokusebenza:OQ
3.3.?PQ(MPQ/PPQ)
Iziqu zokusebenza:PQ(Microbiological PQ/Physical PQ)
3.4.:Ukufaneleka
3.5.: I-Bioburden
3.6.:Inkomba yezinto eziphilayo
3.7.:Umjikelezo wezigaba
3.8.:Uhhafu womjikelezo
3.9.:Umjikelezo ogcwele
3.10.PCD: inqubo inselele idivayisi
3.11.:Umkhiqizo nomndeni womkhiqizo
3.12.?: Ivolumu esebenzisekayo/ivolumu yomthwalo womkhiqizo
3.13.:Inzalo
3.14.SAL: Izinga lokuqinisekisa ukuzala
4. Izibopho
4.1 Unjiniyela wokuqinisekisa we-eto sterilization unomthwalo wemfanelo wokubhala iphrothokholi yokuqinisekisa, futhi abasebenzi abaqeqeshiwe kanye nokusetshenziswa banesibopho sokuqinisekisa nokuqoqa idatha efanele ukusiza ekuqedeni ukuqinisekiswa.
5. Inqubo
5.1.I-IQ yenzelwe ukukhombisa ukuthi okokusebenza kokuvala inzalo kanye nanoma yiziphi izinto ezihambisanayo zinikeziwe futhi zafakwa ngokuhambisana nencazelo yazo. Ngaphambi kokwenza i-IQ, umkhiqizi wezinsimbi uzoqhuba i-FAT ne-SAT ukuze aqinisekise ukuthi okokusebenza kulethwe ngokujwayelekile.